Pharma Manufacturing

Pharmaceutical processors have begun to wield some new tools, nailing down new efficiencies and better drugs in the process.

Maslow wrote, “I suppose it is tempting, if the only tool you have is a hammer, to treat everything as if it were a nail.” For decades, Pharma’s been engineering its own “hammer,” creating development and production methodologies that tended to treat every potential drug candidate like the proverbial nail. To many, Pharma’s hammer became too heavy to wield, not only inefficient at driving Pharma’s traditional solid-dose nails but increasingly ineffective at addressing quality issues at the manufacturing level for biopharmaceuticals. Since FDA promulgated Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, drug makers have invested in its principles slowly if not grudgingly — with some more enthusiastic…

Fewer headaches, reduced complexity and flexibility come with the territory

For biopharma manufacturers, the challenge is clear: quickly and efficiently transfer materials aseptically from one physical area to another, while minimizing the risk of contamination and maximizing efficiency and cost effectiveness. This is especially true for cGMP facilities adapting single-use technology as an operating platform over traditional stainless-steel piping systems. A clear solution to this challenge, however, is more elusive.
TRADITIONAL OPERATIONSHard piping transfer lines require intensive, costly, time-consuming cleaning and validation, with a potential negative impact on productivity and manufacturing flexibility. Hard piping is also challenging to expand or upgrade, involving the task of installing each port through a…

Pharma can take inspiration from industries with mature quality systems and advanced quality capabilities

Quality has a special meaning in pharmaceuticals, where production or distribution errors can jeopardize human life. But other industries face similar challenges, and some have developed sophisticated quality systems. As pharmaceutical companies look for ways to improve their quality practices and performance, they can take ideas from these quality leaders and adapt them for pharma.
Quality can be defined in various ways, from “fitness for purpose” to “meeting customer expectations” to predictability in statistical terms. Each industry understands quality differently, and priorities depend on the specifics of products and markets. In the automotive industry, for instance, companies generally define quality as the ability to meet…

Pharmaceutical processors have begun to wield some new tools, nailing down new efficiencies and better drugs in the process.

Maslow wrote, “I suppose it is tempting, if the only tool you have is a hammer, to treat everything as if it were a nail.” For decades, Pharma’s been engineering its own “hammer,” creating development and production methodologies that tended to treat every potential drug candidate like the proverbial nail. To many, Pharma’s hammer became too heavy to wield, not only inefficient at driving Pharma’s traditional solid-dose nails but increasingly ineffective at addressing quality issues at the manufacturing level for biopharmaceuticals. Since FDA promulgated Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, drug makers have invested in its principles slowly if not grudgingly — with some more enthusiastic…

Santa may have to step up his game on this one

In the mid-1900s (before kids figured out how to use cold meds to make meth) chemistry sets for Christmas were all the rage. Beyond the allure of mixing potentially explosive chemicals in test tubes, these kits inspired generations of kids to get excited about chemistry and perhaps even pursue a future in scientific fields.
As we approach the start of 2015, 3-D printing has collided with drug manufacturing and challenged the idea of traditional chemistry. In a 2012 TED talk, Glasgow University professor Lee Cronin discussed the idea of turning 3-D printers into universal chemistry sets that could actually print their own drugs.
Essentially, Cronin seeks to automate chemistry – or as he has stated in several interviews “app…

Recent

Real-time characterization of Oral Solid Dose formulation in process and nearly prescient control are doing great things for both batch and continuous drug manufacturing

While biopharma’s parenterals may be the belle of the ball lately, Oral Solid Dose’s (OSD) dance card remains booked — the form of choice for thousands of medicines and billions of patients. Far from the dowdy, aging wall flower one might expect from such a mature segment, in reality some of the most exciting technological advancements in Pharma processing are occurring right now as Branded, Generic and CMO players reach out for more speed, more capacity and quality in solid dose cGMP operations.
It’s always worth a moment to take a quick look at the category as a whole, just to calibrate on how important the OSD form is to the Pharma universe. With the exception of one product (Lantus), OSDs represent most prescribed medications.

Novel technologies open a new avenue for developing the future
of pharmaceutical manufacturing

Pharmaceutical manufacturing has been performed using batch technologies for more than a century. While most other manufacturing industries use continuous operations combined with advanced process control and automation, the pharmaceutical industry…

A CPV approach based only on statistical tools addresses only the operational level of the system; management needs to be involved

A company gets a 483 warning letter which, among other things, criticizes the company’s continued process verification (CPV) approach. The observations include inadequate sampling plans, wrong statistical methods used, and company employees do not understand the statistical methods being used. Only a single quality engineer knows how the tools are being used.
So the company scurries about figuring out how to respond including the adoption of better procedures and more clearly explaining the methods being used. So what is the problem here? Who is at fault? The quality engineer? His supervisor? The plant manager? How should this situation be remedied?
The answer is: All of the above with the major portion the responsibility being that of…

Closed-loop systems help pharmaceutical manufacturers save water and energy

While the pharmaceutical industry continues on its road to recovery, sustainability will remain a priority for pharmaceutical manufacturers as they strive for profitable growth. One way many can make significant headway toward true sustainability — and improve the bottom line — is through the use of advanced, closed-loop process cooling technology specifically designed to lower water consumption and save energy.
Process cooling efficiency should be on the front burner rather than the afterthought it often is. Doing so is particularly important today given increasing concern over water use by pharmaceutical manufacturers and other companies that use water-intensive processes to make and deliver products. Following are some…

Recent

When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.

A new New York University analysis found that when the FDA's finds serious problems with how medical researchers collect their data, the peer-reviewed literature often doesn't mention it.Using documents and data from 1998 to 2013, researchers identified 57 clinical trials that received an “official action indicated” violation for reasons including inadequate or inaccurate recordkeeping, false information and poor patient safety.
And yet, among the 78 published analyses of data from those sanctioned trials, only three noted violations.
One example was found where the entire clinical trial was deemed unreliable by the FDA, and the published paper failed to make mention of this. In another example, the published paper claimed all…

New xCELLigence RTCA CardioECR is the first platform for simultaneous measurement of Cardiomyocyte Contractility and Electrophysiology

Responding to the need for more predictive preclinical assays for cardiac liability, ACEA Biosciences introduced a “ground-breaking” device the company describes as “next generation.” Designated the xCELLigence RTCA CardioECR System, it is…

The U.S. attorney’s office has charged Barry Cadden, owner of New England Compounding Center and Glenn Chin, head pharmacist, with 25 acts of second-degree murder in seven states.

The U.S. attorney’s office has charged Barry Cadden, owner of New England Compounding Center and Glenn Chin, head pharmacist, with 25 acts of second-degree murder in seven states in relation to the production of tainted drugs that killed 64 people and sickened hundreds with fungal meningitis in the fall of 2012.
Attorneys claim that the senior execs at the now-closed N.E.C.C. knew of filthy conditions and improper sterility testing.A total 14 people were charged in a 131-count indictment, many of them N.E.C.C. pharmacists. The charges include mail fraud, conspiracy, racketeering and violation of the Food, Drug and Cosmetic Act. Only Cadden and Chin were charged with murder.
Both men plead not guilty in federal court on Wednesday.
Read…

Pharma can take inspiration from industries with mature quality systems and advanced quality capabilities

Quality has a special meaning in pharmaceuticals, where production or distribution errors can jeopardize human life. But other industries face similar challenges, and some have developed sophisticated quality systems. As pharmaceutical companies look for ways to improve their quality practices and performance, they can take ideas from these quality leaders and adapt them for pharma.
Quality can be defined in various ways, from “fitness for purpose” to “meeting customer expectations” to predictability in statistical terms. Each industry understands quality differently, and priorities depend on the specifics of products and markets. In the automotive industry, for instance, companies generally define quality as the ability to meet…

When blockbuster drugs hit the market, they make big news and big profits. But for every blockbuster drug launched, there are an awful lot of disappointments.A good example is Vertex’s launch of the Hepatitis C drug Incivek. It was extremely successful in its first year on the market and heralded in a new era of Hepatitis C therapies. However, that meant competition. It wasn’t too long before newer and better treatments like Gilead’s Sovaldi and AbbVie’s Viekira Pak essentially replaced it in the market. Last spring, Vertex announced that not only is it no longer investing in research or developing new Hepatitis C drugs, it was withdrawing Incivek from the market.Even when we see tremendous therapeutic progress with a drug…

Steady advances in technology have vastly improved the productivity, performance and predictability of scientific work in laboratories for life science organizations. But many challenges remain. Fragmented manual processes, isolated information systems, inconsistencies in methodologies and reliance on paper records can lead to inefficiencies and increased compliance risk.
To stay competitive, today’s life science firms need to implement systems for standardizing the processes that are followed during development, manufacturing and quality assurance/quality control (QA/QC). Standard processes are critical for establishing efficient lab environments, fostering communication among teams, and facilitating externalization for various parts of…

According to Johnson & Johnson, the Geel, Belgium facility produces 54 different types of APIs and three semi-finished APIs, via more than 350 different synthesis steps. In total, the Geel produces +/- 60 % of the total small-molecule API volume within the company. Johnson & Johnson recently updated its Manufacturing Execution System (MES) to PAS-X V3.1.5. The Geel site plays a key role for J&J: there, PAS-X is in operation as full-blown MES in several areas of its API manufacturing lines and warehouse operations. About 300 employees use the system, says Werum, to achieve operational excellence and transparency at the 450.821 m2 site.
“Johnson & Johnson has already implemented Werum’s PAS-X in some plants,” says…

An ongoing pattern of hesitancy exists within the pharmaceutical industry, a reticence that highlights how slow companies are to adopt new technology—an unfortunate trend that is costing companies literally billions of dollars every year. New data indicates that when it comes to Enterprise Quality Management Software (EQMS) implementation, managers are being particularly hesitant to move forward. According to LNS Research in its recently published Research Spotlight “The Cost of Inaction - Taking Quality Management Processes Digital” the industry’s uncertainty about adopting useful technologies like EQMS stems from the same issue: ”While nearly all executives acknowledge that quality is at the core of most business challenges,…

Recent

A new report from FireEye says that a cybercriminal group has been stealing data from more than 100 organizations, mainly targeting publicly traded health care, pharmaceutical and biotechnology companies, to gain insider knowledge to manipulate the stock market.

A new report from U.S. security firm FireEye says that a cybercriminal group known as FIN4 has been stealing data from more than 100 organizations, mainly targeting publicly traded healthcare, pharmaceutical and biotechnology companies, to gain insider knowledge to manipulate the stock market.
FireEye reports that the cybercriminals have targeted the email accounts of individuals privy to the most confidential information of more than 100 companies. According to the report, "FIN4 appears to have a deep familiarity with business deals and corporate communications, and their effects on financial markets. Operating since at least mid-2013, FIN4 distinctly focuses on compromising the accounts of individuals who possess non-public…

Specializing in pain management and fungal disease, Janssen-Cilag Farmacêutica Ltda., is a research-based pharmaceutical company located in São Paulo, Brazil. Janssen-Cilag is a member of the Johnson & Johnson family of companies — the world’s largest personal care and health products manufacturer with worldwide annual sales totaling $63.7 billion. In an effort to streamline business processes, Janssen-Cilag’s Global Pharmaceutical Supply Group (GPSG) Brazil recently adopted a comprehensive enterprise integration solution. As part of its quest for a state-of-the-art IT implementation, GPSG Brazil took advantage of the latest technological advancements from Thermo Scientific in its São José dos Campos laboratory complex in…

Recent

Wockhardt has reported that the U.S. FDA has raised new concerns about its Waluj plant, which is already banned from exporting to the United States over quality issues.

Wockhardt has reported that the U.S. FDA has raised new concerns about its Waluj plant, which is already banned from exporting to the United States over quality issues.
FDA concerns came after a after a week-long inspection of Wockhardt's Waluj manufacturing plant in central India.
The Economic Times reports that the FDA made seven observations, some of which serious in nature, related to quality control, quality assurance, documentation and infrastructure. At least one observation is a repeat from a 2013 inspection.
However, according to a CNBC interview with Wockhardt CEO Habil F Khorakiwala, "Generally observations by U.S. FDA do reflect some of these areas but the question is are they minor and they are correctable? So, there were no…

The FDA inspected the plant in January this year, listing six observations

The U.S. FDA has issued Lupin a Form 483, listing six concerns of its production processes at a plant that produces both oral contraceptives and treatments for eye diseases for sale in the United States in Pithampur in central India.
According to a Reuters article, the FDA inspected the plant in January this year, after which it issued the company a Form 483. Lupin didn't disclose the nature of the observations. Read the full…

Pharma can take inspiration from industries with mature quality systems and advanced quality capabilities

Quality has a special meaning in pharmaceuticals, where production or distribution errors can jeopardize human life. But other industries face similar challenges, and some have developed sophisticated quality systems. As pharmaceutical companies look for ways to improve their quality practices and performance, they can take ideas from these quality leaders and adapt them for pharma.
Quality can be defined in various ways, from “fitness for purpose” to “meeting customer expectations” to predictability in statistical terms. Each industry understands quality differently, and priorities depend on the specifics of products and markets. In the automotive industry, for instance, companies generally define quality as the ability to meet…

A CPV approach based only on statistical tools addresses only the operational level of the system; management needs to be involved

A company gets a 483 warning letter which, among other things, criticizes the company’s continued process verification (CPV) approach. The observations include inadequate sampling plans, wrong statistical methods used, and company employees do not understand the statistical methods being used. Only a single quality engineer knows how the tools are being used.
So the company scurries about figuring out how to respond including the adoption of better procedures and more clearly explaining the methods being used. So what is the problem here? Who is at fault? The quality engineer? His supervisor? The plant manager? How should this situation be remedied?
The answer is: All of the above with the major portion the responsibility being that of…

Pharma can take inspiration from industries with mature quality systems and advanced quality capabilities

Quality has a special meaning in pharmaceuticals, where production or distribution errors can jeopardize human life. But other industries face similar challenges, and some have developed sophisticated quality systems. As pharmaceutical companies look for ways to improve their quality practices and performance, they can take ideas from these quality leaders and adapt them for pharma.
Quality can be defined in various ways, from “fitness for purpose” to “meeting customer expectations” to predictability in statistical terms. Each industry understands quality differently, and priorities depend on the specifics of products and markets. In the automotive industry, for instance, companies generally define quality as the ability to meet…

Pharma can take inspiration from industries with mature quality systems and advanced quality capabilities

Quality has a special meaning in pharmaceuticals, where production or distribution errors can jeopardize human life. But other industries face similar challenges, and some have developed sophisticated quality systems. As pharmaceutical companies look for ways to improve their quality practices and performance, they can take ideas from these quality leaders and adapt them for pharma.
Quality can be defined in various ways, from “fitness for purpose” to “meeting customer expectations” to predictability in statistical terms. Each industry understands quality differently, and priorities depend on the specifics of products and markets. In the automotive industry, for instance, companies generally define quality as the ability to meet…

No matter how complex the supply chain, a careful, methodical process can identify, value and manage those risks, and lead to an insurance policy tailored to your unique needs.

Pharmaceutical manufacturers’ supply chains have become increasingly complex in a globalized economy. There may have been a simpler time when insurance was viewed as a commodity, but today’s policies should be intricately tailored to a company’s specific operations.
In other words, a one-size-fits-all approach to supply chain risk is becoming less and less likely to fit anyone.
Just one example of the existing disconnect is the Business Continuity Institute’s 2014 Supply Chain Resilience Survey, which asked more than 500 stakeholders across 71 countries about supply chain disruptions. More than 80 percent of respondents experienced at least one disruption in the past year, and almost a quarter reported losing $1 million a year from…

A well-designed, reliable raw material storage and conveyance environment can make or break a pharmaceutical manufacturing environment. Raw material storage and conveyance is fundamental to quality assurance and profitability. Increasingly, this environment also has become integral to the rigorous regulatory requirements for tracking and tracing products throughout the supply chain. To meet quality and standardization objectives, a design solution must be based on an overview of the entire process from delivery of raw materials to the manufacturing site to delivery of product ingredients to the manufacturing line. The correct design basis is predicated, particularly, on an understanding of raw material characteristics and facility…

Manufacturing HP active pharmaceutical ingredient drugs is a challenge best met with a thorough assessment of risk and a robust containment strategy

Approximately 25 percent of drugs in development worldwide are classified as highly potent, with this percentage expected to grow over the coming years. A compound is generally classed as highly potent if it has an occupational exposure limit (OEL) of ≤10μg/m3, a daily therapeutic dose of ≤10mg/day or if a 1 mg/kg/day dose produces serious toxicity in laboratory animals. While such highly potent compounds can have significant benefits in the treatment of certain medical conditions, they present substantial challenges to the pharmaceutical industry.
These challenges include:
• Can personnel and the environment involved in the manufacture of high potency products be protected; • Can adequacy of controls preventing contamination of…

Closed-loop systems help pharmaceutical manufacturers save water and energy

While the pharmaceutical industry continues on its road to recovery, sustainability will remain a priority for pharmaceutical manufacturers as they strive for profitable growth. One way many can make significant headway toward true sustainability — and improve the bottom line — is through the use of advanced, closed-loop process cooling technology specifically designed to lower water consumption and save energy.
Process cooling efficiency should be on the front burner rather than the afterthought it often is. Doing so is particularly important today given increasing concern over water use by pharmaceutical manufacturers and other companies that use water-intensive processes to make and deliver products. Following are some…

Closed-loop systems help pharmaceutical manufacturers save water and energy

While the pharmaceutical industry continues on its road to recovery, sustainability will remain a priority for pharmaceutical manufacturers as they strive for profitable growth. One way many can make significant headway toward true sustainability — and improve the bottom line — is through the use of advanced, closed-loop process cooling technology specifically designed to lower water consumption and save energy.
Process cooling efficiency should be on the front burner rather than the afterthought it often is. Doing so is particularly important today given increasing concern over water use by pharmaceutical manufacturers and other companies that use water-intensive processes to make and deliver products. Following are some…

Closed-loop systems help pharmaceutical manufacturers save water and energy

While the pharmaceutical industry continues on its road to recovery, sustainability will remain a priority for pharmaceutical manufacturers as they strive for profitable growth. One way many can make significant headway toward true sustainability — and improve the bottom line — is through the use of advanced, closed-loop process cooling technology specifically designed to lower water consumption and save energy.
Process cooling efficiency should be on the front burner rather than the afterthought it often is. Doing so is particularly important today given increasing concern over water use by pharmaceutical manufacturers and other companies that use water-intensive processes to make and deliver products. Following are some…

Recent

The sale to G&W Laboratories includes about 25 products from the Teva portfolio, which will be manufactured and sold by G&W in the U.S. under the G&W label

Teva Pharmaceutical Industries Ltd. will sell its Sellersville, Pennsylvania, facility to G&W Laboratories Inc. Teva says the sale supports its plans to streamline operations by reducing excess manufacturing capacity and is part of its cost-reduction program.
“Teva is managing its operations to create greater efficiencies and position the company for long-term growth and success. We have a qualified and dedicated team at Sellersville and are pleased that we were able to come to an agreement with G&W Laboratories that will enable them to continue working in their current community,” stated Carlo de Notaristefani, president and CEO of Teva Global Operations.
The sale includes all buildings, land and equipment located at the site.

Layoffs began after completion of the $495 million sale of Dendreon’s prostate cancer drug and other assets

Valeant Pharmaceuticals International is laying off 77 employees at Seattle-based Dendreon’s operations, according to a WARN notice received by the state Employment Security Department.
An article in The Seattle Times said the layoffs began Feb. 23, immediately after completion of the $495 million sale of Dendreon’s prostate cancer drug, Provenge, and other assets.
The article went on to say that Valeant spokeswoman Laurie Little said, “most of these positions were in G&A functions where there was overlap with Valeant’s existing businesses, especially in corporate and back office functions.”
Read the full…

Layoffs began after completion of the $495 million sale of Dendreon’s prostate cancer drug and other assets

Valeant Pharmaceuticals International is laying off 77 employees at Seattle-based Dendreon’s operations, according to a WARN notice received by the state Employment Security Department.
An article in The Seattle Times said the layoffs began Feb. 23, immediately after completion of the $495 million sale of Dendreon’s prostate cancer drug, Provenge, and other assets.
The article went on to say that Valeant spokeswoman Laurie Little said, “most of these positions were in G&A functions where there was overlap with Valeant’s existing businesses, especially in corporate and back office functions.”
Read the full…

The sale to G&W Laboratories includes about 25 products from the Teva portfolio, which will be manufactured and sold by G&W in the U.S. under the G&W label

Teva Pharmaceutical Industries Ltd. will sell its Sellersville, Pennsylvania, facility to G&W Laboratories Inc. Teva says the sale supports its plans to streamline operations by reducing excess manufacturing capacity and is part of its cost-reduction program.
“Teva is managing its operations to create greater efficiencies and position the company for long-term growth and success. We have a qualified and dedicated team at Sellersville and are pleased that we were able to come to an agreement with G&W Laboratories that will enable them to continue working in their current community,” stated Carlo de Notaristefani, president and CEO of Teva Global Operations.
The sale includes all buildings, land and equipment located at the site.

The FTC has finally approved the joint venture between Novartis and GSKin consumer health products, but Novartis must divest its line of nicotine patches.

The Federal Trade Commission has finally approved the joint venture between Novartis AG and GlaxoSmithKline in consumer health products, but Novartis must divest its Habitrol line of nicotine patches.
As per the April 2014 agreement, Novartis will acquire GSK’s oncology business while handing over its vaccines business to GSK. The two companies also decided to merge their consumer healthcare businesses to become a global leader in that segment.
The FTC announced its final order but deemed the Novartis-GSK deal anti-competitive since Novartis and GSK are the only companies that sell branded versions of nicotine patches in the U.S. The FTC thus asked Novartis to divest its Habitrol and private label nicotine patch business, in order to…

Bruker Daltonics

Bruker Daltonics announces its next-generation MALDI-TOF/TOF mass spectrometer. The new Ultraflex III is used in applications like LC-MALDI and MALDI molecular imaging.

Ultraflex III smartbeam laser with computer-controlled settings of the laser focus size from 10 um to 80 um makes it a good choice for MALDI molecular imaging. Absorbing tissue areas can be scanned with a very small laser focus and adjustable repetition rates from 1 Hz to 200 Hz

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